Hospital Parc Taulí
Sabadell, Barcelona, 08208, Spain
Location status: Recruiting
NCT Number: NCT05974384
Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in the emergency room. The initial management, and in many cases definitive, is carried out through manipulation, closed reduction and immobilization in the emergency room. Different methods of anesthesia have been described to reduce pain during the manipulation and reduction procedure, such as: hematoma block, periosteal block, general anesthesia, intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious sedation. Despite the use of different methods of anesthesia, none is fully effective and each of these methods is not free of complications. Adjuvant measures could play an important role in improving the patient's experience during the procedure, however, there is little evidence in this regard.
Music is increasingly being studied and developed as an adjunctive therapy in the management of pain and anxiety in different medical procedures, demonstrating a statistically significant reduction in pain and anxiety. However, in the literature there is no evidence of studies that evaluate the effect of music during the reduction of fractures in traumatology as an adjuvant therapy for the management of pain and anxiety.
In our experience, despite the anesthesia used, reductions of distal radius fractures are usually a painful procedure that involves a certain degree of discomfort for the patient. For this reason, the investigators believe this study is necessary, as it could demonstrate a new adjuvant therapy that reduces pain and anxiety and improves the overall experience of the patient, in addition to being music, a low-cost tool with no risks for patient safety.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Sabadell, Barcelona, 08208, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No listening to music while intervention is carried out
Listening to music while intervention is carried out
Time frame: Will be completed just after the fracture immobilization
It will be completed after the procedure and the punctuation will go from 0 to 10
Time frame: Done just before and after the pfracture immobilization
Puntuation between 20 and 80, 50 considered high anxiety level
Time frame: Will be assessed just before, during and after the fracture immobilization
Measurement of the cardiac frequency assessed before, during and after fracture immobilization
Time frame: Will be assessed just before, during and after the fracture imobilization
Measurement of the blood pressure will be assessed before, during and after fracture immobilization
Time frame: Just after the immobilization, when patient will be discharged
1 to 5 scale for satisfaction with the procedure
Contact information is provided by the study sponsor or research team.
Enrique Cueva, Doctor
CONTACT
937 23 10 10 ext. 21660
Mireia Viñas, Doctor
CONTACT
937 23 10 10 ext. 21660
Corporacion Parc Tauli
Other
Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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